Clinical trial · Interventional
Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Celecoxib | Drug | Celecoxib | ALIAS |
| Long-course radiotherapy | Radiation | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Serplulimab | Drug | Serplulimab | ALIAS |
| Short-course radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Long-course Radiotherapy plus chemotherapy group
- interventionNames
- Radiation: Long-course radiotherapy
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Celecoxib
- Drug: Serplulimab
- type
- EXPERIMENTAL
- label
- Short-course Radiotherapy plus immunochemotherapy group
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Celecoxib
- Radiation: Short-course radiotherapy
- Drug: Serplulimab
Primary outcomes (1)
- measure
- Complete response (CR) rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years, gender not limited 2. Pathologically confirmed rectal adenocarcinoma 3. ≤10 cm from the anus 4. Baseline stage T3-4/N+ 5. No distant metastasis 6. MSI/MMR status MSS/pMMR 7. Karnofsky performance status score ≥70 8. No prior chemotherapy or other anti-cancer treatment prior to enrollment 9. No prior immunotherapy prior to enrollment 10. Ability to comply with the study protocol 11. Written informed consent Exclusion Criteria: 1. Pregnancy or breast-feeding women; 2. Known history of other malignancies within 5 years; 3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc; 4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy); 5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction; 6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment; 7. Uncontrolled infection which needs systemic therapy; 8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents; 9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection 10. Allergic to any component of the therapy.
References
Publications (0)
Data not yet available